SUPPLY CHAIN ARTICLES
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“To Thine Own [mRNA Product] Be True:” Shakespeare's Guide To RNA GMP Principles
In the following article, I offer some of the biggest tips and tricks experts offered during a panel discussion on the challenges of navigating GMP principles in the RNA space today — with a little bit of help from Shakespeare himself.
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Picasso, Pick-Up Lines, & Personalized Medicine: mRNA's Path Forward
Overall, my presentation on what the mRNA industry can learn from the artist Picasso singled out a few specific areas from which I felt our industry could garner greater inspiration and operational prowess. But given how “collaborative” many of these sources of inspiration are, I’ve introduced each of my takeaways with a surprisingly relevant (albeit bad) art-themed pick-up line. After all, if there’s one sector that knows it takes more than one to “tango,” it’s the mRNA industry.
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How Can We Move RNA Forward In Our Therapeutics Arsenal?
RNA technologies, including mRNA therapeutics, have emerged as a promising drug modality. However, they have unique challenges. BioPhorum has dedicated a team to investigate these challenges and this Q&A shares their practical considerations for how to move this field forward.
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The mRNA Supply Chain Revolution: Materials, Methods, And Momentum
mRNA innovation now hinges as much on manufacturing materials as on molecular design, with novel inputs shaping performance, cost, and scalability. As these less-mature materials move rapidly into production, strategic material selection and supplier alignment are becoming critical to manufacturing resilience and long-term success.
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"Mirror, Mirror…": Reflections On Reducing mRNA Production COGS
Here, I outline three overarching words of wisdom I gleaned from Life Edit Therapeutics’ April Sena; Tune Therapeutics’ Tyler Goodwin; and University of Sheffield’s Adi on how the mRNA/RNA industry can better control production costs — particularly as it relates to raw material sourcing and usage.
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Therapeutic Oligonucleotides: Regulations & Quality Standards
Oligonucleotides have surfaced in the past few years as promising therapeutic agents to treat diseases such as neurodegenerative disorders, respiratory disorders, cancer, and diabetic retinopathy. This article recaps a recent USP workshop where participants from regulatory agencies, industry, and academia gathered to discuss best practices and perspectives.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Single-use technology is vital for ensuring the quality and expedited market entry of genomic medicines. Learn how LNP technology is paving the way for a new era of personalized, precise medicine.
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Persistent disruption is redefining biopharma supply chains. Explore how regional manufacturing, integrated risk management, and closer collaboration help build resilience and improve agility.
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Learn how a robust understanding of the RNP’s critical process parameters and CQAs is crucial for ensuring product consistency, enhancing patient safety, and maintaining regulatory compliance.
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GMP-Source, which is a term we coined, serves the purpose as a highly qualified raw material for a generation of virus, messenger RNA template, and transgenic expression of proteins.
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Researchers demonstrate a delivery mechanism that is a simple and ready-to-use transfection reagent that leads to outstanding transfection efficiencies in known hard-to-transfect stem cells.
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As novel mRNA therapies are starting to enter clinical stages of development, Aldevron is providing critical support in a number of ways with specialized products and services.
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Drive the efficiency and resiliency of supply chains by integrating automation, AI, and effective communication, ensuring the successful distribution of lifesaving medicinal products.